Cleared Special

K223436 - Artix AX

K223436 is an FDA 510(k) clearance for Artix AX, manufactured by Inari Medical. The device is a Class 2 Cardiovascular device with product code QEW cleared through the Special 510(k) pathway after a 108-day FDA review.

K223436 · Inari Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
108d
Days
Class 2
Risk

K223436 is an FDA 510(k) clearance for the Artix AX. Classified as Peripheral Mechanical Thrombectomy With Aspiration (product code QEW), Class II - Special Controls.

Submitted by Inari Medical (Irvine, US). The FDA issued a Cleared decision on March 2, 2023 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K223436

510(k) Number K223436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2022
Decision Date March 02, 2023
Days to Decision 108 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

QEW Device Classification - Class 2, Special Controls

Product Code QEW Peripheral Mechanical Thrombectomy With Aspiration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
Definition To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - QEW Peripheral Mechanical Thrombectomy With Aspiration

All 145
Devices cleared under the same product code (QEW) and FDA review panel - the closest regulatory comparables to K223436.
InThrill Thrombectomy System
K223613 · Inari Medical, Inc. · Mar 2023
RevCore™ Thrombectomy Catheter.
K223609 · Inari Medical, Inc. · Mar 2023
Protrieve Sheath
K230331 · Inari Medical, Inc. · Mar 2023
Symphony Thrombectomy System
K223216 · Truvic Medical, Inc. · Feb 2023
Excipio LV Thrombectomy Device
K223897 · Contego Medical, Inc. · Feb 2023
Cobra Catheter System
K223891 · Endovascular Engineering · Feb 2023
K223436 · Artix AX
Download PDF FDA Summary Inari Medical